SAN DIEGO, Calif. ( TheStreet) -- Orexigen Therapeutics ( OREX) released new weight-loss data Wednesday from the second of two obesity drugs in the company's development pipeline. Empatic is a pill that combines the antidepressant bupropion and the anti-seizure medicine zonisamide. In a phase II study, obese patients treated with a high-dose form of Empatic lost an average of 7.5% of their body weight compared to an average weight loss of 1.4% for patients treated with a placebo. Patients treated with a lower dose of Empatic in the study lost an average of 6.1% of their body weight. The trajectory of weight loss from both dosages of Empatic over six months suggests that patients could lose more weight in one-year studies, the company said. The weight loss observed in Empatic patients was also greater than the weight loss of patients treated with the individual components of the drug -- something the FDA requires for combination therapies, the company said. Orexigen called the mid-stage study of Empatic a success and said it plans to meet with Food and Drug Administration officials to discuss a phase III study program. The most commonly reported adverse events for all Empatic patients were headache, insomnia and nausea. The most common adverse events leading to discontinuation were insomnia, headache and urticaria (hives). There were no statistically or clinically meaningful differences between Empatic and placebo on measures of cognitive function, depression, suicidality or anxiety, the company said. Orexigen has already completed phase III studies of its first obesity drug, Contrave, and expects to seek FDA approval in the first half of next year. Contrave consists of two currently approved drugs combined together to suppress appetite and fight food cravings. One of the drugs in Contrave is naltrexone, currently used to fight opioid and alcohol addiction; the other drug is the antidepressant bupropion. SEE ALSO: Biotech Calendar for October
Orexigen faces competiton in the weight-loss drug arena from Arena Pharmaceuticals ( ARNA - Get Report) and Vivus ( VVUS - Get Report), both of which are also seeking regulatory approval for their respective obesity drugs.
The biggest improvement for FTY720 is on the safety side, where the low dose of the drug showed no increase in infection risk compared to placebo. The cancer rate for FTY720 was lower in this new trial than in a previous trial, including no reported cases of breast cancer.